Nouvelle déclaration d'incident
No de la demande: 2014-5655
Numéro de référence du titulaire d'homologation: 2014CK426
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 77 Belfield Rd
Ville: Toronto
État: ON
Pays: Canada
Code postal /Zip: M9W 1G6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-141
Nom du produit: k9 advantix II small dog
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
papillon
1
Homme
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Approximately 12 hours post application, the canine developed a loss of balance (ataxia), began vomiting, had a loss of muscle control (musculoskeletal disorder NOS), and had an unspecified number of seizures of unknown intensity. The canine was examined by a veterinarian and unknown treatments were provided.The canine died on 03Jul2014 from unknown causes. No known necropsy examination was performed.
Mort
Loss of balance (ataxia) and vomiting are more expected after oral uptake than after dermal application of the product. Potential oral uptake was not reported. Musculo-skeletal disorder e.g. loss of muscle control not expected after product application as inconsistent with pharmacotoxicological profile of the product. However likely coincidental and other causes (e.g. foreign body in paw or trauma) are more probable. It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. Though rather close time to onset, more likely coincidental occurrence or dog may have predisposition for idiopathic seizures. Time to onset is consistent (12 hours) for signs. Death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Limited information (weight, medical history and necropsy not available) was provided in the email correspondence from the owner and the health status of the dog prior to product application was unknown. Other etiologies (e.g. seizures) are more probable. However, considering all aspects, a product involvement remains unassessable